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Quality Assurance and Regulatory Compliance Specialist
hace 2 meses
Overview
Position Summary
The Quality and Regulatory Affairs (QA/RA) Trainee plays a crucial role in supporting the execution of regulatory affairs functions related to both pre-market and post-market activities. This includes assisting in the preparation of essential documentation and information necessary for maintaining product market presence, such as regulatory submissions, licensing, and registrations.
Key Responsibilities
- Aids in ensuring the company is duly registered and adheres to relevant national and international regulations.
- Collaborates in the preparation and submission of regulatory documents for market clearance, licensing, and registration.
- Supports the implementation of global corrective actions and product recalls.
- Assists in regulatory affairs interactions across various company functions, including senior management, while providing support to the Tender and Sales departments to meet customer requirements, including but not limited to: Declarations of Conformity, EC Certificates, Instructions for Use, Labelling, Lot Certificates, and Safety Data Sheets.
- Ensures accurate and up-to-date documentation is maintained in the company's Information Systems for tasks under their responsibility.
- Upholds compliance with the Werfen Code of Ethics.
Networking and Key Relationships
This role may involve collaboration with the Tender Office, Sales and Marketing Office, Service Office, Supply Chain Office, and regulatory contacts of represented companies or manufacturers.
Required Knowledge and Experience
Education: A degree in a scientific, finance, or administration discipline, or equivalent relevant experience.
- Experience: Not required.
- Additional Skills/Knowledge:
- Familiarity with local and international regulatory requirements.
- Proficient computer skills: MS Office, experience with enterprise resource planning systems (ERP), and other regulatory software tools.
- Language proficiency: Spanish and English.
Skills and Competencies
- Strong commitment to compliance with regulations and procedures.
- Excellent written and verbal communication abilities.
- Team-oriented with a collaborative spirit.
- Detail-oriented with a focus on delivering results.
- Customer-centric approach with effective relationship management skills.
- Adaptability and flexibility in a dynamic environment.
